Technicon Autoslide Staining/Processing
FDA 510(k) K781598 · Technicon Instruments Corp.
510(k) numberK781598
Submission
- Device name
- Technicon Autoslide Staining/Processing
- Applicant
- Technicon Instruments Corp.
Mchenry, IL, US - Received
- September 18, 1978
- Decision date
- October 17, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code KPA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K933996 | ProfiblotKPA · Traditional | Tecan U.S., Ltd. | 01/28/1994SE |
| K884258 | VersablotKPA · Traditional | American Bionetics, Inc. | 12/14/1988SE |
| K881592 | Wescor Model 7300 Aerospray Gram StainerKPA · Traditional | Wescor, Inc. | 05/13/1988SE |
| K880745 | LX-100 Slide StainerKPA · Traditional | Innovative Medical Systems, Inc. | 04/27/1988SE |
| K874887 | Wesblot ProcessorKPA · Traditional | American Bionetics, Inc. | 03/24/1988SE |
| K874897 | Sakura DRS-60 Automatic Slide StainerKPA · Traditional | Sakura Finetek U.S.A., Inc. | 01/05/1988SE |
| K872916 | Histomatic Slide Stainer, Code-On VersionKPA · Traditional | Fisher Scientific Co., LLC | 09/14/1987SE |
| K853210 | MST-1050-II X-Ray UnitKPA · Traditional | Radiological Engineering, Inc. | 10/10/1985SE |
| K850333 | Pump Tube Sets for Hema-Tek I & II Slide StainersKPA · Traditional | Shaban Mfg. Co. | 02/27/1985SE |
| K850157 | Cannulas for Hema-Tek I & KK Slide StainersKPA · Traditional | Shaban Mfg. Co. | 02/27/1985SE |
More from Shaban Mfg. Co.
| 510(k) | Device | Decision |
|---|---|---|
| K914888 | Technicon Chem 1(TM) Syst (GEN2 Syst)CIX · Traditional | 11/27/1991SE |
| K914511 | Technicon Axon(Tm) System Methods Anyalye HDL CholLBS · Traditional | 11/27/1991SE |
| K914025 | Technicon Axon(Tm) Systems, Alt(P 5-P)/AST(P 5-P)CIT · Traditional | 11/22/1991SE |
| K912616 | Technicon Immuno 1 TM System Additional AnalytesKLI · Traditional | 09/25/1991SE |
| K912413 | Chem-Link Data Base ManagerJJQ · Traditional | 07/01/1991SE |
| K903825 | Drug of Abuse Analysis SystemDIS · Traditional | 09/27/1990SE |
| K903824 | Drug of Abuse Analysis System Free Radical AssayDKZ · Traditional | 09/27/1990SE |
| K903305 | Technicon Chem I System Carbon Dioxide MethodKHS · Traditional | 09/27/1990SE |
| K903306 | Technicon Chem I System Magnesium MethodJGJ · Traditional | 08/29/1990SE |
| K901410 | Technicon RA-2000(TM) SystemJJC · Traditional | 07/17/1990SE |
Questions and answers
When was Technicon Autoslide Staining/Processing cleared by the FDA?
Technicon Autoslide Staining/Processing (K781598) received a 510(k) decision of Substantially Equivalent on October 17, 1978, 29 days after the submission was received.
What is the product code of K781598?
The FDA product code is KPA – Slide Stainer, Automated, a Class I (low risk) device regulated under 21 CFR 864.3800.